MAUDE Adverse Event Report: TOSOH CORPORATION AIA-2000

Model Number AIA-2000

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at customer site to address the reported event.The fse confirmed the reported errors by reviewing the error log and reproduced the problem by running quality controls (qc).The complaint was resolved by correcting the main arm alignment.The instrument was validated by running qc; results passed and were within published ranges.The instrument software was later updated to version 2.09 per t-205e.No further action required by field service.The aia-2000 instrument is functioning as expected.The aia-2000st, serial number (b)(4), was installed at the account on (b)(6) 2019.A complaint history review and service history review for similar complaints was performed from (b)(6) 2019 through aware date 02oct2019.There were no other complaints identified during the searched period.The aia-2000 operator's manual under appendix 4: error messages states the following: 2061 - tip detachment failure by main arm cause : a tip was detected by tip detachment check.If retry fails, the measurement result will be flagged (mf flag).Solution : contact tosoh service center or local representatives.4223 - main arm z-axis home overrun.Cause : the home sensor activated improperly after movement of the main arm z-axis.If retry fails, the measurement result will be flagged (mf flag).Solution : contact tosoh service center or local representatives.2070 - clogging detected during specimen suction by main arm cause : the negative pressure detected after specimen suction exceeded the standard.The specified amount of specimen may not have been obtained because the sampling nozzle was blocked.The measurement result will be flagged (sc flag).Solution : verify that the specimen is free of solid substances (such as fibrin) or that there is sufficient volume of specimen if it is prepared in the primary tube, retry the measurement.If retry fails, contact tosoh service center or local representatives.The probable cause of the reported event was due to the mis-alignment of the main arm and a required software update.

Event Description

A customer reported getting error 2061 tip detachment failure by main arm during a run on the aia-2000 instrument.Tech support (ts) had the customer stop the run and perform an all set home.The analyzer was reset, and customer ran another sample to see if the error would happen again.The customer then received error messages 4223 main arm z-axis home overrun.The customer called back to report now receiving error message 2070 clogging detected during specimen suction by main arm.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of estradiol (e2), and follicle stimulating hormone (fsh) patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

Manufacturer Narrative

A review of the device history record (dhr) was conducted for serial number (b)(6) which confirmed that there were no nonconformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.

• Brand Name: AIA-2000
• Type of Device: AIA-2000
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• MDR Report Key: 9268451
• MDR Text Key: 220568440
• Report Number: 8031673-2019-00415
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-2000
• Device Catalogue Number: 022100
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 11/01/2019
• Supplement Dates Manufacturer Received: 11/19/2019
• Supplement Dates FDA Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1